Hi Molla,
The question is not really easy to answer but I'll try.
On the ISO 13485, the infrastructure is to define "what you need to get a good product and good environment for your employees".
So this really depends on your structure and which product you have.
Let's take some examples.
- Your products are sold sterile, so you need to have a clean room. You need then to have procedures in place to validate your clean room so it can provide the right environment for your product. You should have procedures to maintain the environment in the Clean Room.
- So this is one example. But if you are final cleaning your products, you need also to have a monitoring of your water system to see if it is compliant to the specification of your products.
- If you have a place to store your products and that your products are temperature sensitive, then you need to have some sensors to alert when the temperature is not on the range.
All this to say that it depends on the specification of your products.
The other part is about the specification so your employees are also in a good environment of working. For example, safe environment without chemical vapors, or no dust that can be damaging the lungs...
You see that this topic is really critical.
So what I advice is to follow a Risk Analysis process defining the specification of the products and safety of the employees. And wherever you find a risk you need to identify a way to mitigate that risk. This is the
FMEA process which means Failure Mode and Effect Analysis.
This is not an exercise you can do alone so I suggest you do that with employees that know about the infrastructure of the building and the equipment.
I hope this helps you to start but this is really something that works on a case by case. So cannot provide a strategy for something that is really custom-made for you.
Wish you the best.